Medical Devices

De Novo Classification Request(De Novo)

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

Usage Examples

The AI-based diagnostic received De Novo classification.
Following De Novo grant, competitors filed 510(k)s citing it as predicate.
FDA established special controls as part of the De Novo decision.

What is De Novo?

The De Novo classification pathway provides a route to market for novel medical devices that are low-to-moderate risk (Class I or II) but have no predicate device for 510(k) comparison. Without this pathway, such devices would default to Class III and require PMA.

De Novo requests must demonstrate the device can be classified as Class I or II with general controls (and special controls for Class II) sufficient to provide reasonable assurance of safety and effectiveness. Once granted, the De Novo device becomes a predicate for future 510(k) submissions.

De Novo is commonly used for innovative devices, digital health products, and devices using novel technology or intended uses.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 860, FDCA SECTION 513F2.

FDA CDRHEMAHealth Canada

When This Matters

The AI-based diagnostic received De Novo classification.
Following De Novo grant, competitors filed 510(k)s citing it as predicate.
FDA established special controls as part of the De Novo decision.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 860FDCA SECTION 513F2

Frequently Asked Questions

510(k) demonstrates equivalence to an existing predicate device. De Novo is for novel devices with no predicate, establishing them as Class I or II and creating a new predicate for future 510(k)s.

FDA targets 150 review days, but actual time is often 9-12 months or longer due to questions, additional information requests, and administrative processing.

Both paths are available. Direct De Novo submission is preferred when no predicate exists. After receiving Not Substantially Equivalent (NSE) for a 510(k), sponsors can submit a De Novo request within 30 days.